1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
Patheon Italia S.p.A. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
3Stability and storage
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2024-11-27. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
